Randomized Placebo Controlled Trial of Closed Loop S8mula8on in Recurrent Reflex Vasovagal Syncope. SPAIN Study.
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1 Randomized Placebo Controlled Trial of Closed Loop S8mula8on in Recurrent Reflex Vasovagal Syncope. SPAIN Study. Gonzalo Baron- Esquivias MD, PhD, FESC. Carlos A. Morillo, MD, FRCPC, FACC, FHRS, FESC Angel Moya- Mitjans MD, PhD, FESC Jesus Mar8nez- Alday MD, PhD Ricardo Ruiz- Granell MD, PhD Javier Lacunza- Ruiz MD. Roberto Garcia- Civera MD, PhD Encarnacion Gu8errez- Carretero MD, PhD Rafael Romero- Rodriguez MD
2 NO CONFLICTS OF INTEREST
3 30.20 sec
4
5
6 !
7 VVS PM Randomized not placebo controlled published studies PM vs No Therapy VPS Connolly S.J. et al. JACC 1999;33:16-20 PM vs No Therapy VASIS Sutton R. et al. Circ 2000;102: PM vs MED TREAT. SYDIT Ammirati F. et al. Circ 2001;104:52-57
8 PM vs no- PM: p=0.7 Baron- Esquivias G; Eur Heart J, 2002; 23: 483-9
9 VVS PM Randomized double blinded RCT s PM on vs PM off VPS II (n=100) Connolly S.J. et al. JAMA 2003; 289: PM on vs PM off SYNPACE (n=29) Raviele A. et al. Eur Heart J 2004; 25:
10 DDD- CLS PM and syncope During VVS: VV Venous return Sympathetic compensatory tone Inotropic effect Chronotropic state Closed Loop Stimulation Response of Closed Loop Stimulation HEART RATE CONTRACTILITY NO SYNCOPE
11 DDD- CLS in VVS PM on vs PM off INVASY Ochetta E. et al. Europace 2004; 6: DDD-CLS vs DDD convencional Palmisano P et al. Europace 2012; 14:
12 DDD- CLS in VVS DDD-CLS vs DDD convencional Kanjwal K et al. J Interv Card Electrophysiol 2010; 27: DDD-CLS pre vs DDD-CLS on Bortnik M. et al. J Cardiovasc Med 2012; 13; 242-5
13 2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy Indication for cardiac pacing in patients with undocumented reflex syncope Class Level 2) Tilt-induced cardioinhibitory syncope Pacing may be indicated in patients with tilt-induced cardioinhibitory response with recurrent frequent unpredictable syncope and age >40 years after alternative therapy has failed IIb B 3) Tilt-induced non-cardioinhibitory syncope Cardiac pacing is not indicated in the absence of a documented cardioinhibitory reflex III B 5) Tilt-induced cardioinhibitory syncope In patients with cardioinhibitory vasovagal syncope, dual-chamber pacing is the preferred mode of pacing. I C Eur Heart J 2009; 30: Eur Heart J 2013;34:
14 OBJECTIVE To determine in a randomized prospecsve double- blind placebo- controlled cross- over mulscentre trial the uslity of DDD- CLS pacing in pasents with cardioinhibitory refractory neurally reflex VVS.
15 METHODS
16 INCLUSION CRITERIA: (PaSents must fulfil all those 8 criterias) 1) At least 5 previous neuromediated syncope episodes (at least 2 of them occurring within last year). 2) PosiSve Tilt- test, cardioinhibitory response: Heart rate <40 bpm for at least 10 ' or > 3 pause. 3) 40 years old. 4) Absence of cardiomyopathy and normal 12- lead electrocardiogram 5) No other type of pacemaker indicason. 6) Geographical stability and availability to assist to follow- ups. 7) Signed consent form. 8) None any of the following contraindicasons: ß- blockers drug treatment, Chronicle polyneuropathy and any contraindicason to DDD or DDDR pacing. EXCLUSION CRITERIA: 1) PaSents that not fulfil any of the inclusion criteria described above. 2) PaSents with syncope caused by carosd sinus hypersensisvity. 3) Other cause of syncope (known cause and different from neuromediated syncope). 4) PaSents that parscipate in any other invessgason study. 5) Pregnant or breast- feeding women that are not making use of at least 2 contracepsve methods.
17 1) 2) 3) 4) 5) All pasents underwent: Complete physical exam including orthostasc test. CaroSd sinus massage. 12- lead electrocardiogram. 2D- Doppler echocardiography 24- h Holter monitoring All normal HUT Protocols: TILT- TABLE TEST 1.- Basal, 60º, 45 minutes or 2.- Italian (400 μgr nitroglicerin)
18 Enrollment GROUP A Central Randomiza8on 2 blind inves8gators/centre GROUP B 1st AllocaSon Allocated inisally to DDD- CLS Allocated inisally to DDI- sham Follow- up 12 months or Sll 3 syncope in one month 2nd AllocaSon Change to DDI- sham pacing mode 12 months or Sll 3 syncope in one month. Change to DDI- CLS pacing mode Follow- up 12 months or Sll 3 syncope in one month 12 months or Sll 3 syncope in one month Analysis Analysis
19 OUTCOME Primary Efficacy Outcome: To determine the effect of DDD- CLS in reducing by >50% the overall number of syncope episode compared to the DDI sham placebo mode. Co- Primary efficacy outcome: - Time to first recurrence of syncope in both pacing mode sequences: Group A vs Group B. - Time to first recurrence in both groups (DDD- CLS vs DDI).
20 STATISTICAL ANALYSIS Data was collected and analysed by an independent database company, PIVOTAL S.L. ConSnuous variables were expressed as median [interquarsle range IQ] when their distribuson was not normal, and as mean ± SD otherwise Shapiro- Wilk test, and these variables were compared by Mann Whitney and Wilcoxon (signed Rank) or Student t- test. The Fisher or chi- square test was used for comparison of qualitasve data and McNemar or Q of Cochran when data were couples. To analyse the primary efficacy endpoint, differences between groups A and B, Mainland- Gart and PrescoZ test were used. The cumulasve risk of syncope over Sme was essmated using the Kaplan Meier procedure and long- Rank test, for correlason between treatment and Sme to recurrence. A two- tailed P value<0 05 was considered significant. Predefined number of pasents: 50 Data were analysed with version 9.4 of SAS souware.
21 RESULTS
22 Randomized (n=54) Enrollment GROUP A GROUP B 1st AllocaSon Allocated inisally to DDD- CLS (n=22) Received DDD- CLS PM (n=22) Allocated inisally to DDI (n=32) Received DDI PM(n=32) Lost of Follow- up during DDD- CLS pacing (n=1) Did not accept blind at the end of 12 months (n=1) Follow- up 2nd AllocaSon Change to DDI pacing mode (n=20) Lost Follow- up during DDI pacing (n=2) Protocol deviason (n=4) Insuficient data available (n=2). Change to DDI- CLS pacing mode (n=24) Follow- up Follow- up during DDI pacing (n=20) Follow- up during DDD- CLS pacing (n=24) Analyzed (n=21) Analyzed (n=25)
23 CLINICAL CHARACTERISTICS n=46 Age Males 56 ± 10.6 y.o. 47.8% Previous syncopal episodes (SE) 12 [IQ9, IQ20] Previous SE during last 12 months 4.5 [IQ2, IQ7] Asystole during HUT (%) 35 (76) Asystole durason (sec) 15 [IQ10, IQ26]
24 CLINICAL CHARACTERISTICS Group A: DDD- CLSà DDI Group B: DDIà DDD- CLS (n=21) (n=25) p Age (y.o.) Weight (kg) Height (cm) Male (%) High Blood Pressure (%) Diabetes (%) Previous Syncopal Episodes (SE) Previous SE during last 12 months OrthostaSc test 56.9 ± [IQ66, IQ90] 164 ± (42,8) 6 (28) 1 (4) 12 [IQ10, IQ20] 4.5 [IQ3, IQ7,5] 55.9 ± [IQ61, IQ83] ± (52) 8 (32) 0 (0) 10 [IQ8, IQ20] 4.5 [IQ2, IQ6] Asystole in HUT (%) Asystole durason (sec) 16 (79) 14.3 [IQ7, IQ29] 19 (76) 15 [IQ10, IQ22]
25 Primary Efficacy Outcome Mailand- Gard Test (CI 95%) 1st period of treatment 2nd period of treatment 50% reducson in the number of syncopal episodes (95%CI 46.52, 90.31) % reducson in the number of syncopal episodes (95%CI 9.69, 53.48) 100 (95%CI 39.76, ) p= PrescoZ analysis Prefers the 1st period (n=18) Prefers the 2nd period (n=4) Does not have preference (n=7) Total (n=29) Fisher test Group A: DDD- CLS<<DDI 13 (72.22) 0 (0.00) 0 (0.00) 13 (44.83) p= Group B: DDI>>DDD- CLS 5 (27.78) 4 (100.00) 7 (100.00) 16 (25.17)
26 Primary Efficacy Outcome Propor8on of pa8ents with > 50% reduc8on in syncope burden > 50% ReducSon Syncope Burden DDI- Sham Mailand- Gard Test p = DDD- CLS DDD- CLS PrescoZ analysis p = Group A. DDD- CLS- - >DDI Sham n = 29 Group B: DDI Sham- >DDD- CLS
27 Co- Primary Efficacy Outcome (DDD- CLS vs DDI) Number of pa8ents suffering syncopal recurrence 50 Pa8ents without syncope (45.65%) (8.70%) DDD- CLS (n=46) Number of pasents Number of pasent without events Number of pasents with events Pa8ents with syncope DDI- SHAM (n=46) DDD- CLS pacing mode DDI sham pacing mode (91.30%) 25(54.35%) 4(8.70%) 21 (45.65%)
28 Co- Primary Efficacy Outcome (Group A vs B) DDD-CLS >> DDI 1.0 DDI >> DDD-CLS Group B: 9.30 months (95% CI: 6.21 to NA) p = Group A: months (95% CI: to 29.19) Syncope Event Rate Months since Randomization Patients at Risk DDD-CLS >> DDI DDI >> DDD-CLS
29 Co- Primary Efficacy Outcome (DDD- CLS vs DDI) DDD CLS DDI 1.0 DDI pacing mode: 9.30 months (95% CI, 6.61, ) Log- rank test: p < DDD- CLS pacing mode: Not aplicable Syncope Event Rate Months since Randomization Patients at Risk DDD CLS DDI
30 Co- Primary Efficacy Outcome (DDD- CLS vs DDI) Time to first syncope (Median (95%CI) IQ25% - 75% DDD- CLS pacing mode DDI sham pacing mode NA (12.99, NA) 9.30 (6.61, 19.07) NA Odds RaSo (95% CI , ) Risk of Syncopal Recurrence 8.82 (1/OR) Absolute Risk ReducSon NNT = (1/ARR) * 100 Cox model over Sme to event DDI vs DDD- CLS p= (Smes greater DDI than DDD- CLS) 37% (45.65% 8.70%= 37%) 2.7 Hazard raso (95% CI) (95%CI , ) p=0.0005
31 CONCLUSION DDD- CLS pacing compared to sham pacing in pasents 40 yo with cardio- inhibitory refractory reflex VV syncope: ü Significantly reduced syncope burden. ü 7- fold reducson in the recurrence of syncope. ü Significantly prolonged Sme to 1st syncope recurrence.
32 AKNOWLEDGENTS INSTITUTIONS & INVESTIGATORS SPAIN: H. Universitario Virgen del Rocio, Seville: G Baron- Esquivias, E GuSerrez. H. Universitario Ntra Señora de la Candelaria, Tenerife: R Romero, J Hernández. H. Universitario de Bellvitge, Barcelona: X Sabaté. H. Universitario Virgen de Valme, Sevilla: J Leal del Ojo, D Garcia- Medina. H. Universitario Lluis Alcanyis, XáSva, Valencia: M Rodríguez, A Viñuales. H. Universitario Vall d Hebron, Barcelona: A Moya- Mitjans, C Alonso. Clínica Vicente San SebasSán, Bilbao: J Mar nez- Alday, JM Ormaetxe. H. Universitario Virgen de la Arrixaca, Murcia: FJ Lacunza, A García- Alberola. H. Universitario Puerta Hierro, Madrid: I Fernández- Lozano, V Castro, C GuSérrez. H. Universitario Morales Meseguer, Murcia: JA Ruiz- Ros, A. Carnero. CANADA: Hamilton General Hospital, Calgary, Alberta: C Morillo.
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